A Laboratory Information Management System or Laboratory Integration Management Solution (LIMS) is a software system used in laboratories for the integration of laboratory software and analytical instruments and the management of samples, laboratory users, standards and other laboratory functions such as Quality Assurance (QA) and Quality Control (QC), sample planning, invoicing, plate management, and workflow automation. LIMS software may also support information gathering, decision making, calculation, review and release into the workplace and away from the office. More recently, LIMS software are starting to expand into Electronic Laboratory Notebooks, assay data management, data mining and data analysis.
One core function of a LIMS is the management of samples. This typically is initiated when a sample is received in the laboratory at which point the sample will be registered in the LIMS. This registration process may involve accessioning the sample and producing barcodes to affix to the sample container. Various other parameters may be recorded as well, such as clinical or phenotypic information corresponding with the sample. The LIMS may then track chain of custody of the sample as well as the sample location. Location tracking often involves assigning the sample to a particular location such as a shelf/rack/box/row/column. Other event tracking may be required such as freeze and thaw cycles that a sample undergoes in the laboratory.
Modern LIMS have implemented extensive configurability as each laboratories needs for tracking additional data points can vary widely. LIMS vendors often cannot make assumptions about what these data tracking needs are and therefore need to be adaptable to each environment. LIMS users may also have regulatory concerns to comply with such as CLIA, HIPAA, GLP and FDA specifications and this can affect certain aspects of sample management in a LIMS solution. One key to compliance with many of these standards is audit logging of all changes to LIMS data, and in some cases a full electronic signature system is required for rigorous tracking of field level changes to LIMS data.
One may configure a LIMS whereby users are assigned roles or groups. Typically the role of a user will dictate their access to specific data records in the LIMS. Each user account is protected by security mechanisms such as a user id and a password. Users may have customized interfaces based on their role in the organization. For example, a laboratory manager might have full access to all of a LIMS functions and data, whereas laboratory technicians might have access only to data and functionality needed for their individual work-tasks.
Some LIMS offer some capability for integration with analytical instruments. A LIMS may create control files that are “fed” into the analytical instrument and direct its operation on some physical item such as a sample tube or sample plate. The LIMS may then import instrument results files to extract QC or results data for assessment of the operation on the sample or samples. Data owners may access the resulting stored information at any time. Typically, the LIMS operate using instructions which are generated in a first message format and the analytical instruments operate by receiving commands in a second message format which is different from the first message format. As a result, in order to communicate between the LIMS and the analytical instrument, the instructions routinely need to be converted into commands, and vice versa, using one of a variety of known techniques.
Currently, in one technique, some LIMS communicate with analytical instruments through a series of hardware interface cards which are instrument-specific and therefore vary with respect to the type of analytical instrument they are being installed on or connected with. Each hardware interface card must be installed on or connected with a particular type of analytical instrument. The hardware interface card may translate instrument data into a standardized language which is then communicated with a host computer, providing for a universal interface between the analytical instrument and the host computer. Often, the host computers are then connected with a remote computer upon which the LIMS software resides. Having to design and manufacture a hardware interface card for each analytical instrument for which the LIMS needs to communicate with, can be rather costly.
Alternatively, in another technique, specific software can be written for and loaded onto each analytical instrument to be used as a “dedicated” interface. A dedicated interface is one that is designed to operate with only one type of computer or one type of analytical instrument. Although not as convenient, dedicated interfaces can be used to overcome specific hardware issues which arise with universal interfaces. Nevertheless, a dedicated interface is not as convenient as a universal interface, and may require software to be written for and loaded onto each analytical instrument.
Finally, using a last technique, a client computer generates instructions in a first message format using specific information obtained about the analytical instrument. Those instructions are then communicated with the analytical instrument using the LIMS, which is often centrally located on a remote computer. In some instances, the specific information about the analytical instrument includes its logical location and operational parameters, so that then client computer may generate instructions in a first message format which are then sent to the LIMS and later converted into commands in a second message format different from the first message format, in order to induce operation of the analytical instrument. Without knowledge of this specific information, the client computer is unable to generate the instructions.
It would be desirable to provide a simplified method for allowing a LIMS to communicate between a plurality of remote analytical instruments which does not require the use of a specialized hardware interface cards or specific software to be written for and loaded onto each analytical instrument. It would also be desirable to provide a simplified method for allowing a client computer of a LIMS to communicate between a plurality of remote analytical instruments which does not require the client computer to have access to specific information about the analytical instrument, such as the logical location or operational parameters for the analytical instrument.